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Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Renzapride

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Constipation-predominant irritable bowel syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females with constipation predominant IBS as defined by the Rome II criteria Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease Exclusion Criteria: Patients who have diarrhoea predominant or alternating symptom IBS Other gastrointestinal diseases that affect bowel transit

Sites / Locations

Alizyme

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Renzapride 4 mg QD. Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Renzapride 2 mg BID: Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Outcomes

Primary Outcome Measures

Number of months a patient is a Responder for overall relief of IBS symptoms

Secondary Outcome Measures

Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention

Full Information

NCT ID

NCT00268879

First Posted

December 22, 2005

Last Updated

February 13, 2008

Sponsor

Alizyme

1. Study Identification

Unique Protocol Identification Number

NCT00268879

Brief Title

Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)

Official Title

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alizyme

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.

Detailed Description

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function. In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of their symptoms throughout the study. The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome, Constipation-predominant irritable bowel syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1821 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Arm Title

Arm Type

Experimental

Arm Description

Renzapride 4 mg QD. Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Arm Title

Arm Type

Experimental

Arm Description

Renzapride 2 mg BID: Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Intervention Type

Drug

Intervention Name(s)

Renzapride

Other Intervention Name(s)

ATL-1251, BRL-24924

Intervention Description

Placebo Renzapride 4 mg QD Renzapride 2 mg BID

Primary Outcome Measure Information:

Title

Number of months a patient is a Responder for overall relief of IBS symptoms

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Lembo

Organizational Affiliation

Beth Israel Deaconess Medical Centre, Boston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alizyme

City

Cambridge

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)

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